Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05401760 |
| Other study ID # |
R.22.05.1718 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2022 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to report the effectiveness of phacoaspiration when combined with
angle surgery in preventing postoperative glaucoma following pediatric cataract surgery
Description:
As postoperative glaucoma could be the consequence of a dysgenesis of the iridocorneal angle
that accompanies the dysgenesis of the lens so, the hypothesis states that combined
phacoaspiration with angle surgery may be superior to phacoaspiration as standalone procedure
in controlling IOP within the normal range postoperatively after pediatric cataract surgery
• Patients with pediatric cataract will be subdivided into 2 groups: Group A: includes eyes
for whom combined phacoaspiration & angle surgery will be done.
Group B: includes eyes for whom phacoaspiration only will be done. All surgeries will be
performed in Mansoura Ophthalmic Center by the same surgeon or under his supervision.
Preoperative:
1. History: Full ocular & general history will be taken Ocular history: history of ocular
trauma, ocular surgeries & wearing glasses. General medical history: age, history of any
associated neurologic, metabolic or systemic disease or drug intake.
2. Examination: Full ocular examination will be done
- Anterior segment examination using (Topcon or Zeiss surgical microscopes) or (Zeiss
or hag streit slit lamps).
- Corneal diameter will be measured.
- Fundus examination using indirect ophthalmoscope (KEELER Vantage Plus indirect
ophthalmoscope) if the fundus is visible.
- IOP measuring using Schoitz tonometer.
- Refraction (if the eye can be refracted) & K readings will be measured using
portable autorefractometer (Retinomax K-plus2).
3. Investigations:
- Axial length, anterior chamber depth & Ocular biometry will be measured using
(Nidek Al-Scan Optical Biometer).
- B-scan will be done using (Nidek Us-4000 Echoscan).
- Ultrasound biomicroscopy (UBM) scan will be performed using (VuMAX HD).
Intraoperative:
1. Group A: for whom combined phacoaspiration & angle surgery ither trabeculotomy will be
done. I
- Partial thickness scleral flap to access the canal of schlemm.
- 2 side ports will be fashioned.
- Trypan blue will be injected to aid visualization of the anterior capsule &
continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will
be done.
- The nucleus and cortex will be aspirated.
- Posterior capsulrehxis and limited anterior vitrectomy will be done.
- Corneal incisions will be sutured with 10-0 Nylon suture.
- Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal
of schlemm.
- Suturing of scleral flap with 10-0 Nylon suture.
2. Group B: for whom phacoaspiration only will be done.
- 2 side ports will be fashioned.
- Trypan blue will be injected to aid visualization of the anterior capsule &
continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will
be done.
- The nucleus and cortex will be aspirated.
- Posterior capsulrehxis and limited anterior vitrectomy will be done.
- Corneal incisions will be sutured with 10-0 Nylon suture.
Postoperative:
1. All patients will be discharged on:
- Systemic &topical antibiotic eye drops.
- Topical steroids.
- Cycloplegic eye drops.
- Combined antibiotic and steroid eye ointment.
2. Topical Steroids & cycloplegic eye drops will be gradually withdrawn over a period of 3
months.
3. The eyes will be carefully examined at each follow-up visit (1 week, 2 weeks 1months and
3 months).
4. During each visit:
- Anterior segment examination will be done.
- Measuring of:
- Corneal diameter.
- Cup/disc ratio.
- IOP using Schoitz tonometer.
- Axial length, anterior chamber depth.
